Sr Principal Quality Eng Vision Care R&D
*THIS POSITION CAN BE LOCATED IN FORT WORTH, TX OR JOHNS CREEK, GA. RELCOATION IS AVAILABLE.
The Vision Care R&D Sr Principal Quality Engineer for Dry Eye & Ocular Health (DEOH) is responsible to ensure that new development products/processes and post market performance improvements are developed, validated and implemented with quality by design principles and state of the art development / design control / risk management practices. Responsible for the design, execution and monitoring of all Quality Systems related to Pharma development and Medical Device Design Control within the Vision Care R&D franchise. Collaborates with cross-functional team for design transfer, continuous product verification and lifecycle support during post-market phase to ensure product remains in a safe and reliable state.
• Responsible for the design, execution, and monitoring of all Quality Systems related to Drug development, Design Control, Six Sigma, and product quality attributes, process design space analysis within R&D Vision Care franchise in support of all new product launches and ongoing product improvements for the DEOH products.
• Assures the successful development, documentation, quality control, validation, and transfer of high quality and reliable products and confirm the alignment of the Vision Care R&D organization complies with the applicable quality policies, procedures, systems, and assures the product Design History File is thorough, accurate and complete throughout the product life cycle.
• Assures that quality is designed into product attributes and processes. Assures accurate and appropriate supporting documentation; assures compliance of all R&D activities within the product development and post market performance monitoring process.
• Work directly with Regulatory Authorities to ensure timely product introductions along with needed leadership for regulatory sustainability of current commercial products.
• Directs the Vision Care R&D franchise staff to be competent and skilled in the implementation of design control quality policies, procedures, systems, and regulatory requirements.
• Guides the global product and process improvement for newly launched products as well as continuous improvements discovered during product lifecycle by providing training and mentoring in problem solving, Six Sigma and other quality system tools.
• Provides on-going Quality by Design Engineering input to ALCON staff to continuously improve the new product development process to deliver best in class outcomes, more reliable products, more robust processes, and timely, cost effective results.
• Provides product and process quality guidance to global Manufacturing Site Quality and Engineering organizations to assure successful transfer of new reliable products into the worldwide marketplace.
• Provides input into post-market post-production risk reviews and process to ensure product is performing in accordance with established risk mitigations. Situations that warrant an adjustment to the risk mitigations will be managed through the post-market surveillance teams.
• Provides front room audit support for corporate, notified body and health authority audits.
Ensures VC R&D operations and product development projects are in compliance with Health Authority, Notified Body and Novartis/Alcon Quality guidelines Ensures product Design History File documentation and technical product documentation remain current and in compliance with regulatory guidelines.
Ensures successful transfer of new products into manufacturing and monitors the performance during the first year of product transfer for quality issues, yield and product performance problems.
Ensures product remains in a safe and reliable state through the transfer from development to manufacturing as well as conducting post market product reviews to address product reliability and safety issues.
Meets individual goals and objectives defined in annual objectives
Models and promotes the Novartis Values and Behaviors
Sr Principal Quality Eng Vision Care R&D
Bachelor's Degree or equivalent years of directly related experience The ability to fluently read, write, understand and communicate in English 7 Years of Relevant Experience
Relocation available/No Sponsorship.
Fort Worth, TX
QUALITY ASSURANCE AL
Alcon Laboratories, Inc.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
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